TOPIC: Should There Be MORE Or Less Regulation On Supplements?
The FDA is working on some new possible rules for regulating dietary supplements, and in the past year, many popular supplements have been banned. Should the FDA put more regulations on supplements and supplement manufacturers to keep the consumers safe from dangerous products (or dangerous marketing tactics)?
Or should the FDA leave the market alone and give the the consumers the freedom to decide what they want to use?
The best response will get $50 in credit to use in our online store!
1st Place - Lok7y
I don't really think you can paint this as a 'black-and-white' issue. There really are shades and gradations when it comes to issues such as these.
Now, regarding supplements themselves, I tend to take a very libertarian view of supplement-use. It's your body--you should have every right to be able to put what you choose to into your body, assuming you know the consequences.
However, why I can't state the above as an absolute is because of that final clause, the "consequences" part. And this is where it gets extremely tricky. Invariably, when one has a product with appeal, it will be picked up and used by some who have not taken the time to adequately inform them selves about the product.
Case-in-point: I have seen post after post on various boards across the internet detailing 17aa-1-Testosterone usage by individuals who clearly
- do not understand that it is a steroid,
- are ignorant about proper protocol for using ANY steroid, and
- essentially picked it up solely on word of mouth without doing any investigative research into it before beginning their cycle.
But, at the same time, I feel that even something as potent as M1-T CAN conceivably be used 'safely' in the hands of an individual who takes the proper precautions and is extremely versed in what they are doing.
So in general, I would like to see:
- No amendments to the DSHEA or anything that deprives the market of specific 'supplements' so that--as I said above--individuals can make informed decisions about what is available to them and use it.
FDA Authorized Claims
Yes, claims for foods and dietary supplements are FDA (Food and Drug Administration) authorized and regulated, contrary to what the media would have you think...
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- Stricter guidelines regarding label-claims. The industry is rife with products that either
- don't meet label claims,
- make label claims that cannot be corroborated &/or are not backed by any valid scientific research, and/or
- are pure hyperbole.
I think this is one area where the FDA could be doing a far better job in actively assuring quality and that products actually
- are what they claim to be and
- provide the benefits they claim to provide. Obviously, I understand this is a business, and some degree of 'marketing our products' has to be allowed for. All the same, there are some gross and egregious acts of exaggeration and deception that have occurred in this industry, and I think it's easily time a stop is put to the vast majority of them.
- An age-ban on androgens/anabolic substances. 18 (perhaps 21). I realize that age =! maturity or intelligence, but--generally-- I think this would have been beneficial had it been instituted long ago. Obviously now this last point is moot in light of the upcoming ban. Shame too.
2nd Place - JSMB
Before answering the questions posed for this week, it's important to take a look at exactly what the regulations are that the FDA plans to implement. Without that information, formulating an informed opinion is somewhat difficult, if not impossible.
FDA's task is to ensure that dietary supplements, when used under conditions recommended by the labeling, or, in the absence of labeling, under normal conditions, do not pose an "unreasonable risk of illness or injury."
In making these decisions, the agency relies most heavily on history of use, aggregated reports of adverse events, and reliable, proven studies of the product or ingredient in question. Their decisions are not made for arbitrary or political reasons.
The FDA announced a regulatory strategy for further implementation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) on November 4 (See: http://www.fda.gov/bbs/topics/news/2004/NEW01130.html).
Their strategy can be broken into three areas:
- monitoring and evaluation of product and ingredient safety,
- assurance of product quality by finalizing a regulation governing "current good manufacturing practice" and
- monitoring and evaluation of product labeling.
FDA Monitoring And Product Evaluation
Until passage of DSHEA the FDA did not make a determination as to whether a supplement posed an unreasonable risk, until after that product was on the market.
However, DSHEA required the Agency to begin making pre-market determinations for any product introduced after October 15, 1994 that contained a "new dietary ingredient"
A supplement is by law deemed to be adulterated unless it includes an NDI that "has been present in the food supply as an article used for food in a form in which the food has not been chemically altered," or "[A] history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe," and the company producing the supplement has provided the FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
FDA faces the task of establishing criteria for how manufacturers inform the Agency of the "other evidence of safety" proving that their product is reasonably safe. The FDA has also begun moving to examine products introduced after October 15, 1994, that contain NDIs and for which the manufacturer has not provided adequate reason to deem them unadulterated.
That, really, is the crux of the issue. Obtaining that data, for a new product, one that truly has no history within the food supply, can be extremely expensive and those costs would be passed on to consumers.
On the upside, it certainly would weed out any company trying to sell bodybuilders a bunch of snake oil. The trade off is between paying more for supplements that have been shown to be at least reasonably safe and not terribly likely to kill or injury you and paying less for supplements that may or may not be dangerous.
The effectiveness of the products, on the other hand, is another question unto itself. Supplement manufacturers can refuse to overtly affirm that their product will result in a given effect but hint at it in their advertising (in which case, it becomes an issue for the FTC and the FDA together, i.e., false advertising).
Product Quality And Assurance
The second aspect of the FDA's regulatory initiative is to ensure good manufacturing practices in the facilities that manufacture the things bodybuilders and others are going to be putting into their mouths.
For example, are the plants ensuring that their manufacturing processes monitor and correct for problems with super potent and sub potent products, wrong ingredients, presence of contaminants (e.g., bacteria, pesticide, glass, and lead), under filled containers, foreign material in a container, improper packaging, and mislabeling.
All of these requirements cost money, of course, which will be passed on in the form of higher prices to the consumer, but I for one, would rather not be stirring rat droppings into my protein shake in the mornings and am willing to pay a few more cents for a reasonable assurance that the manufacturer is looking out for such things and will, if I find one, at least be fined, or disciplined by the FDA.
The third aspect of the regulatory initiative is to ensure the accuracy of labeling. Labeled claims about the effect of the supplement on the structure or function of the body, general well-being from consumption and benefits related to classical nutrient deficiency diseases are not subject to pre-market approval by FDA (although they require pre-market notification to the FDA and a disclaimer statement on the label stating that those claims have not been validated by the FDA).
However, claims about use of the supplement to diagnose, prevent, mitigate, treat, or cure any non-nutrient deficiency disease are prohibited. The FDA is concerned that individuals with serious diseases could be mislead by labels on dietary supplements and the will be working to ensure that supplement manufacturers comply with the law in this regard.
So, there's what the regulatory initiative is all about.
If you want to read more about the whole thing, you can read the text of the statute the regulations are based on at: http://thomas.loc.gov It's Public Law 103-417).
You can read a description of the regulatory initiative here: http://www.cfsan.fda.gov/~dms/ds3strat.html
And, more important, if you want, you can actually participate in the regulatory process. The Administrative Procedures Act requires Federal agencies issuing regulations to accept public comments on most of their proposed regulations and guidelines.
The FDA has solicited public comment on the criteria it should use for establishing whether or not an NDI has been shown to be reasonably safe. Many companies are providing the Agency with information to demonstrate the safety of their supplements, but there are no consistent guidelines for what that information should consist of, or how it should be validated.
The Agency, therefore, has asked that the interested public let it know what their thoughts are. These criteria, as mentioned above, are the real crux of the issue. If these guidelines are very stringent, it will cost supplement manufacturers a great deal to prove the safety of their NDIs and those costs will be passed on. If those guidelines are more general, then the cost of proving their safety will be lower.
You can review a comprehensive list of proposed guidelines that the FDA is considering here: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-23439.htm under Section IV. If you want to comment on the proposed guidelines, you should go here: http://www.accessdata.fda.gov/scrip...CID=&AGENCY=FDA
Keep in mind, when you comment, that you must be specific and to the point. You must cite the exact proposed guideline you wish to comment on and stick to that issue.
Now, as to whether the FDA should impose more regulations on supplement manufacturers, or let people decide on their own what they're going to ingest? In one sense, this question is a moot point, since the law requires such regulations and there is nothing the Agency can do to avoid that. So if you REALLY want this all to go away, you'd have to start a serious lobbying campaign for legislative change, which is only slightly more likely to happen than President Bush mailing off a gold embossed invitation to Osama Bin Laden to join him for tea and biscuits in the Rose Garden.
The real issue is how stringent the requirements will be for manufacturers trying to prove the safety of their new dietary ingredients, and how firmly they will enforce the good manufacturing practices and the labeling requirements, because the FDA does have administrative latitude in deciding those issues.
With regard to the first question, I am in favor of stronger, rather than more lax requirements. When it comes to my personal health and safety, I'd rather be on the safe side and am willing to pay a few more cents to have the peace of mind that comes from an adequate regulatory scheme. But that is also a reflection of the fact that I have made a firm decision not to use any supplements other than whey powder, flax oil and occasionally a children's multi-vitamin.
I would feel like I was somehow cheating myself out of the lessons of weightlifting, out of the achievement of it, if my success was dependent on something other than my own will power, dedication and hard work.
On the latter two questions, I am more in favor of strong regulations. I'd like to be reasonably assured that the products I'm getting are accurately represented on their labels so that I can at least have an uninterested party to counter all of the marketing hoopla. I'd also like to be sure that the manufacturing processes engaged in to produce those supplements result in a safe product. One without any rat droppings, or human thumbs, that actually weighs 5 pounds, not 4.75.
Everyone is, of course, free to read the documents I've cited and make up their own mind.
3rd Place - Chewwy
The bodybuilding industry is now saturated with products in a wide array of potencies, all claiming to increase growth, recovery time etc. These go from the natural, essential supplements such as whey protein, to the dangerous and drastic synthol.
Where to draw the line as to what is acceptable for an athlete to legally use is a debatable issue, and one we will discuss in this article.
The governing body regarding this issue in the United States is Food and Drug Administration, or FDA for short. While this organization in principle only has the power to change laws in the USA, it usual for other countries to follow suit.
Furthermore, if a product is to be made illegal in the USA, this gets rid of a large chunk of the producers market, and so the product may be discontinued.
The Case FOR More Regulation:
Of course, in order to be banned, a product must actually be attributed to health risks, and it is widely acknowledged that these substances that are banned are banned for a reason.
In fact, most people accept that a lot of legal substances indeed cause unsightly health problems, and that they all too often fall into the hands of young, uneducated bodybuilders looking for a quick way to get big. Dangerous substances are easily and relatively cheaply available to those who want to use them, and this situation means problems are rife to occur.
Most supplements, especially the newly emerging ones, with the most drastic results, are very much un-researched, meaning the full extent of its side-effects remains unknown.
In this day and age, where the culture of the law-suit is rife, it is sensible for the FDA to ban any products which potentially cause health problems, if nothing else to be safe.
The Case AGAINST:
This side of the argument revolves mainly around the point that it is the athlete's own choice what substances they wish to put inside them. It should be noted that the FDA controls what products are deemed suitable for 'everyday use, and that sporting associations, for example the IFBB, have the right disallow or conveniently disregard whatever substances they deem suitable for their competitions, and this article is not discussing that issue.
It should be expected among any serious athlete that they will have researched all affects of whatever they plan on taking, and concluded that any negative side-affects are outweighed by the product's positive selling point.
Any damage done will only be upon the athlete's own body, and so it seems ridiculous that people are still allowed to purchase guns and other deadly weapons over the counter, while products such as Ephedera and Androstenedione, which at the most pose(d) mild health risks to the individual, according to sometimes circumstantial evidence, are outlawed.
Nowadays, everything known to man has been proven one way or another to negatively affect one's health and through articles freely available to the public, everyday people make choices as to what to put inside them, knowing of the consequences. We cannot live our lives wrapped up in cotton wool, protected from everything with adverse side-affects. If this was so, and was what our governing bodies actually wanted, then smoking, alcohol, and fatty foods would all have been banned long ago.
The fact is, if people really want to get their hands on the most powerful steroids, they will, regardless of the law. So, rather than banning them completely, and creating an underground trade network, the persona of these substances should be changed.
The reputation of steroids has been hyped up over the past few decades, to the point where they are the supposed staple diet of pros. This is due mainly to people in general, and their reasoning of how people get to that size, rather than the big companies behind these products.
This attitude needs to be changed, not only to solve this problem, but also for the greater good of the sport, which currently has the ugly aura of steroids looming over it, casting all of it's greatness in darkness.
Rather than an all-out ban on substances, it would be wiser for the FDA to ensure stricter product labeling and advertising procedures, and possibly make certain substances only available 'prescription only', ie. After an interview with a qualified professional, like a personal trainer/nutritionist.